NICE recommends brigatinib for treating ALK-positive advanced non-small-cell lung cancer

NICE recommends brigatinib for treating ALK-positive non-small-cell lung cancer after crizotinib

NICE recommends brigatinib for treating ALK-positive advanced non-small-cell lung cancer.

Takeda UK Ltd has announced that the National Institute for Health and Care Excellence (NICE) has recommended ALUNBRIG (brigatinib) for treating anaplastic lymphoma kinase (ALK)-positive advanced non-small-cell lung cancer (NSCLC) in adults who have already had crizotinib, within a final appraisal document (FAD).

This positive recommendation has resulted from close collaborative working between Takeda, NICE, NHS England, and the clinical and patient community to reverse the draft negative recommendation published in October 2018.

ALK-positive NSCLC is a rare type of lung cancer that mainly affects younger people (median age 52 years vs. 70 years in the total lung cancer population) and non-smokers and there continues to be a significant unmet need in this treatment resistant disease.

Brigatinib is a next-generation ALK inhibitor that will provide eligible patients with a targeted therapy that has demonstrated efficacy against the cancer in the lungs and the secondary cancer in the brain, and has a generally manageable side effect profile.

Debra Montague, Chair of ALK Positive UK commented on the recommendation: “As a person with ALK-positive NSCLC, I can speak for myself and the people I represent at ALK Positive UK, when I say that we are extremely pleased that NICE has recommended brigatinib. As a non-smoker and woman in my fifties, I was shocked to receive my diagnosis two years ago. I never thought that lung cancer would be something I’d have to face because, like many people, I’d always associated it with smoking and people in their 70s.

“Many of us with ALK-positive NSCLC face the fear of treatment failure and progression in the brain every time we visit the hospital for a scan. We face the possibility of our limited options running out. Treatments like brigatinib are vital for the ongoing survival of patients that progress after receiving treatment with crizotinib; it is so important for ALK-positive NSCLC patients and their families that brigatinib will now be available on the NHS.”

Dr Sanjay Popat, Consultant Thoracic Medical Oncologist at The Royal Marsden Hospital in London said: “There remains an unmet need for advanced ALK-positive NSCLC – a rare and aggressive type of lung cancer. The decision from NICE to recommend brigatinib post-crizotinib is welcomed by the clinical community as it provides us with a chance to extend survival but also to protect the brain from metastases. This combination of systemic and intracranial efficacy, plus generally manageable side effect profile, will make brigatinib an important treatment option for patients that have relapsed on first line crizotinib.”

Jon Neal, General Manager, Takeda UK Ltd, said: “We are extremely pleased that NICE has recognised the value that brigatinib can bring to the ongoing survival of ALK-positive NSCLC patients that have progressed after crizotinib.”